Browsing by Author "Correale, Jorge"
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Item Clinical implications for substandard, nonproprietary medicines in multiple sclerosis: focus on fingolimod(Dove Press Limited, 2016) Correale, Jorge; Chiquete, Erwin; Boyko, Alexey; Beran, Roy; Strauch, Jorge; Milojevic, Snezana; Frider, NadinaBoth proprietary and nonproprietary medicines are expected to undergo rigorous preapproval testing and both should meet stringent health authority regulatory requirements related to quality to obtain approval. Nonproprietary (also known as copy, or generic) medicines, which base their authorization and use on the proprietary documentation and label, are often viewed as a means to help lower the cost and, thus, increase patient access. If these medicines fail to meet quality standards, such as good manufacturing practice and bioequivalence (in humans), they are then defined as substandard copies and can pose serious risks to patients in terms of safety and efficacy. Potentially noncontrolled or different manufacturing process and excipients in nonproprietary medicines may result in poor batch-to-batch reproducibility (accurate and consistent quantity of each ingredient in each capsule/tablet) and lower quality. Substandard, nonproprietary copies of medicines that are immunomodulatory or immunosuppressive are of concern to patients due to their possible untoward safety and lack of efficacy events. This article reviews the potential risks associated with nonproprietary medicines that do not meet the regulatory requirements of the United States Food and Drug Administration, the European Medicines Agency, or the World Health Organization. The clinical implications for patients are described. This article focuses on nonproprietary medicines for multiple sclerosis, particularly fingolimod, that are not identical to proprietary versions and could thus fail to meet efficacy expectations or have different impact on the safety of patients with multiple sclerosis.Publication Core data set para la generación de datos de la vida real en esclerosis múltiple: adaptación de una iniciativa global para América Latina(2024) Rojas, Juan; Gracia, Fernando; Parciak, Tina; Alonso, Ricardo; Becker, Jefferson; Treviño, Irene; Alonso, Marina; Giunta, Diego; Abad, Patricio; Carnero, Edgar; Carrá, Adriana; Correa, Edgar; Correale, Jorge; Cristiano, Edgardo; Flores, José; Fruns, Manuel; Galleguillos, Lorna; Garcea, Orlando; Hamuy, Fernando; Lana, Marco; Navas, Carlos; Pappais, Regina; Patrucco, Liliana; Rivera, Víctor; Tenembaum, Silvia; Ysrraelit, María; Peeters, LiesbetIntroduction: The primary objective of the core data set is to reduce heterogeneity and promote harmonization among data sources in EM, thereby reducing the time needed to execute real life data collection efforts. Recently, a group led by the Multiple Sclerosis Data Alliance has developed a core data set for collecting real-world data on multiple sclerosis (MS) globally. Our objective was to adapt this global data set to the needs of Latin America, so that it can be implemented by the registries already developed and in the process of development in the region. Material and methods: A working group was formed regionally, the core data set created globally was adapted (translation process into Spanish, incorporation of regional variables and consensus on variables to be used). Consensus was obtained through the remote Delphi methodology of a round of questionnaires and remote discussion of the core data set variables. Results: A total of 25 professionals from Latin America carried out the adaptation process between November 2022 and July 2023. Agreement was established on a core data set of nine categories and 45 variables, version 2023 to suggest its implementation in developed or developing registries, and MS cohorts in the region. Conclusion: The core data set seeks to harmonize the variables collected by registries and cohorts in MS in Latin America in order to facilitate said collection and allow collaboration between sources. Its implementation will facilitate real life data collection and collaboration in the region.Item Optimizing outcomes in multiple sclerosis: consensus guidelines for the diagnosis and treatment of multiple sclerosis in Latin America(2011) Carrá, Adriana; Macías, Miguel Angel; Gabbai, Alberto Alan; Correale, Jorge; Bolaña, Carlos; Duriez, Eduardo; García, Juan; Vergara, Fernando; Vizcarra, DarwinObjective: The prevalence of multiple sclerosis (MS) in Latin America varies across different studies but an intermediate risk and increased frequency of the disease have been reported in recent years. The circumstances of Latin American countries are different from those of Europe and North America, both in terms of differential diagnoses and disease management. Methods: An online survey on MS was sent to 855 neurologists in nine Latin American countries. A panel of nine experts in MS analyzed the results. Results: Diagnostic and therapeutic recommendations were outlined with special emphasis on the specific needs and circumstances of Latin America. The experts proposed guidelines for MS diagnosis, treatment, and follow up, highlighting the importance of considering endemic infectious diseases in the differential diagnoses of MS, the identification of patients at high risk of developing MS in order to maximize therapeutic opportunities, early treatment initiation, and cost-effective control of treatment efficacy, as well as global assessment of disability. Conclusions: The experts recommended that healthcare systems allocate a longer consultation time for patients with MS, which must be conducted by neurologists trained in the management of the disease. All drugs currently approved must be available in all Latin American countries and must be covered by healthcare plans. The expert panel supported the creation of a permanent forum to discuss future clinical and therapeutic recommendations that may be useful in Latin American countries.